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Viewray Incorporated recalls MRIdian¿ ViewRay¿ Radiation Therapy System, ViewRay¿ Is indicated for stereotactic radiosurgery and precision radiot
Recalled October 21, 2015 · FDA recall Z-0115-2016 · Viewray Incorporated
Hazard
ViewRay discovered that in the event that an encoder breaks or fails on the Patient Handling System (PHS, or couch), when attempting to restart the system, the couch could move unexpectedly. · FDA Class II
Units
4 units
Sold at
US Distribution to the states of : CA, MO and WI., and Internationally to Korea.
Description
ViewRay discovered that in the event that an encoder breaks or fails on the Patient Handling System (PHS, or couch), when attempting to restart the system, the couch could move unexpectedly.
Product
MRIdian¿ ViewRay¿ Radiation Therapy System, ViewRay¿ Is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
Manufacturer(s)
Viewray Incorporated
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →